Coronary Artery Disease, Myocardial Ischaemia
Conditions
Brief summary
The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.
Detailed description
ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.
Interventions
OTHERITS plus OMT
Invasive treatment strategy plus optimal medical therapy
OTHEROMT
Optimal medical therapy alone
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80 * Patients with chronic coronary syndromes * Signed written informed consent
Exclusion criteria
* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled) * Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) * Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III) * Inability or unwillingness to undergo CT scan or coronary angiography * Patients on hemodialysis or with severe hepatic or renal insufficiency * Left main coronary artery stenosis ≥ 50% * Target vessel total occlusion * Pregnancy or intention to become pregnant during the course of the trial * Patients with a life expectancy less than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) | 1 year | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 1 year | All-cause death and cardiac death. |
| MI | 1 year | Target vessel related and non-target vessel related MI. |
| Revascularization | 1 year | Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization. |
| Stroke | 1 year | Stroke (ischemic and hemorrhagic). |
| Cost-effectiveness analysis | 1 year | Medical expenses of treatment and follow-up. |
| Quality of life assessed by Seattle Angina Questionnaire | 1 year | Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire. |
| MACE | 1 month, 2 years, 3 years, 5 years | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. |
Countries
China
Contacts
CONTACTJian'an Wang, MD
PRINCIPAL_INVESTIGATORJian'an Wang, MD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed